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[V7-S3] Efficient Utilization of Disease Registry Data in Drug Development
Session Chair(s)
Satoshi Teramukai, PhD
Professor, Department of Biostatistics
Kyoto Prefectural University of Medicine, Japan
Efficient utilization of disease registry (or cohort) data is of current interest to streamline drug development, especially for rare diseases. We can use this data as historical data when planning a trial design or evaluating the efficacy and safety of an investigational drug. The PMDA has also examined the potential utility of disease registry data for New Drug Applications. This session will discuss issues concerning utilization of disease registry data in drug development, including case studies.
Speaker(s)
Expectation for the Disease Registry Data from a Pharmaceutical Company
Kazuhito Shiosakai
Daiichi Sankyo Company, Limited, Japan
Manager, Statistical Analysis Group, Biostatistics & Data Management Department
Promoting Eficiency of Drug Development Using Disease Registry Data
Akihiro Hirakawa, PhD
Institute of Science Tokyo, Japan
Professor, Department of Clinical Biostatistics
PMDA Perspective:Utilization of the Disease Registry Data for Drug Development
Akiko Hori, MD, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Review Director, Office of Regulatory Science